Kornimate/medical-research-clean huggingface dataset:
lung ultrasound score after ent cancer surgery

Conditions: Cancer of Head and Neck; Tracheostomy; Postoperative Pulmonary Complication; Surgery

Summary: after ent cancer surgery, postoperative respiratory complications are common, especially after tracheostomy. the objective of this study is to characterize the pulmonary status of patients after ent cancer surgery. we wish to collect and analyze the pulmonary abnormalities revealed by the ultrasound scans performed in the post-anesthesia care unit (pacu), at day 1 and at day 2 after ent cancer surgery with tracheostomy.

after ent cancer surgery, postoperative respiratory complications are common, especially after tracheostomy. problems with lung ventilation called "atelectasis" are largely associated with these complications. these atelectasis develop within minutes of the start of general anesthesia. patients who develop a complication require longer postoperative oxygen treatment and more physical therapy. the diagnosis of atelectasis can be made by standard chest radiography, which is a source of radiation and requires moving the patient. an alternative technique, lung ultrasound, is a non-irradiating examination that can be performed in the patient's bed. it is routinely performed in the postoperative surveillance room and in the intermediate care unit at the centre léon bérard. the objective of this study is to characterize the pulmonary status of patients after ent cancer surgery. we wish to collect and analyze the pulmonary abnormalities revealed by the ultrasound scans performed in the post-anesthesia care unit (pacu), at day 1 and at day 2 after ent cancer surgery with tracheostomy.

Eligibility criteria:
inclusion criteria: * ent cancer surgery with tracheostomy or tracheotomy exclusion criteria: * under 18 years old * deprivation of liberty * pre-existing tracheotomy or tracheostomy * patient refusal

Keywords: postoperative pulmonary complication lung ultrasound tracheostomy ent cancer surgery
study of the safety of brolucizumab 6 mg in prefilled syringe in patients with neovascular age related macular degeneration

Conditions: Neovascular Age Related Macular Degeneration

Summary: this was a multicenter, open label study that is designed to evaluate the safety of brolucizumab 6 mg in a prefilled syringe in subjects with neovascular age related macular degeneration and to support collection of observations of the prefilled syringe use for intravitreal injection.

the primary objective of this study was to evaluate the safety of brolucizumab 6 mg delivered in a pre-filled syringe (pfs) in subjects with neovascular age-related macular degeneration (namd) with the primary endpoint being the incidence of ocular and non-ocular adverse events (aes). there were no other objectives for this study.

Eligibility criteria:
inclusion criteria: 1. written informed consent must be obtained before any assessment is performed. 2. study eye is diagnosed with neovascular age related macular degeneration and would need an intravitreal injection. 3. subjects \>= 50 years of age. exclusion criteria: 1. active infection or inflammation in the eyes. 2. uncontrolled glaucoma. 3. history of a medical, ocular or non-ocular conditions, resulting in that the study medication cannot be safely administered. 4. treatment with anti-vegf intravitreal injection in the study eye within one month prior to enrollment. 5. the use of intraocular corticosteroids in the study eye within the last three months prior to enrollment. 6. recent intraocular surgery, prior long-acting therapeutic agent, or ocular drug release device implantation. 7. uncontrolled hypertension. other protocol defined inclusion and exclusion criteria may apply.

Keywords: brolucizumab 6 mg prefilled syringe pfs open label study neovascular age related macular degeneration intravitreal injection ivt observation
multi-center observational study on the progression of atherosclerotic plaques in anti-pd-1 mab treated tumor patients by artery ultrasound follow-up

Conditions: Plaque, Atherosclerotic; Programmed Cell Death Protein 1 Inhibitor

Summary: multi-center observational study on the progression of atherosclerotic plaques in anti-pd-1 mab treated tumor patients by artery ultrasound follow-up

this is a self-control, multi-center observational study. this study aims to evaluate the effectiveness of anti-pd-1 mabs on atherosclerotic plaques in those anti-pd-1 mabs treated patients. the method for quantification and evaluation of atherosclerotic plaques are based on the calculation of the plaque area of atherosclerotic plaques on the long axis direction of artery on the ultrasound images. by comparing the plaque areas at the same location of artery in each patient before and after anti-pd-1 mabs treatments, to assess the progression of atherosclerotic plaques response to anti-pd-1 mabs.

Eligibility criteria:
inclusion criteria: 1. the age is 18-90 years old (including 18 and 90 years old); 2. the subjects knew about the experiment and signed the informed consent voluntarily; 3. the subjects complicated with tumor diseases and atherosclerotic plaques; 4. the subjects received regular pd-1 inhibitor treatment; 5. the subjects had ultrasound images of atherosclerotic plaques before- and after- or during pd-1 blockade treatment at the two different timepoints; 6. the subjects received regular treatments of pd-1 inhibitor during the two timepoints of artery ultrasound examinations; 7. the subjects who had ultrasound images before the initiation of first-dose pd-1 inhibitor, the interval between these two timepoints should be restricted within 1 month; 8. the subjects who had ultrasound images after 3 months of pd-1 inhibitor treatment. exclusion criteria: 1. subjects stop receiving pd-1 inhibitor treatments during follow-up; 2. subjects are reluctant to continue to be involved in this study; known pregnant and lactating women; 3. plaque areas can not be calculated because of the quality of ultrasound image; 4. other situations that the researchers judged were not suitable for inclusion.

Keywords: atherosclerotic plaque pd-1 inhibitor artery ultrasound
feasibility of cryobiopsy from the bile duct - cryleo

Conditions: Neoplasms, Bile Duct

Summary: this is a multi-center, prospective, feasibility study using a 1.1 mm flexible cryoprobe su via percutaneous access in the bile duct. the device has a ce-approval. first feasibility and safety for application assessed in the bile duct performed ex vivo and in a patient case report study. the study will take place at 5 different sites in germany. recruitment is competitive. in total, 15 patients will be enrolled. patients are screened for study inclusion at the participating hospitals. primary objective: • feasibility of percutaneous cryobiopsy in the bile duct secondary objectives: * size of biopsy (mean area (in mm2) of each biopsy technique) * percentage of successful retrievals of biopsies by each biopsy technique * representativeness of each biopsy sample * quality of each biopsy sample * grade of crash artifacts occurrence defined as crush artifact area per biopsy * rate of safety-relevant aspects, like for example bleeding, post-bleeding, perforation, infection and abscess


Eligibility criteria:
inclusion criteria: * suspicion of any neoplastic alterations in the bile duct system or other indication for biopsy sampling in the bile duct * a percutaneous drainage or an access by means of percutaneous transhepatic cholangiodrainage (ptcd) has been previously established independent from study participation, without adverse events * patient is at least 18 years of age * according to physicians' assessment, patient is able to follow study protocol or is able to understand the nature, objectives, benefits, implications, risks and inconveniences of the clinical investigation, able to comply with study requirements and understand and independently sign the informed consent form exclusion criteria: * • presence of hereditary bleeding disorder, e.g. hemophilia a or hemophilia b * severe impairment of partial thromboplastin time (ptt) of \>80s; international normalized ratio (inr) \>3; platelet count \<50,000 /nl * dual antiplatelet therapy (change to aspirin monotherapy is no exclusion criterion) * current use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended amount of time prior to an invasive procedure (aspirin monotherapy is no exclusion criterion) patient is participating in another clinical study pregnant or breast-feeding or intending to get pregnant during the study
complications in pediatric mechanical circulatory assistance: evaluation of infection management.

Conditions: Heart Failure; Implant Infection

Summary: end-stage heart failure in children is a rare cause of infant mortality. the most frequent cause is dilated cardiomyopathy, often of undetermined origin, which can lead to cardiogenic shock refractory to standard medical treatment. in such cases, it is essential to resort to exceptional means, available at tertiary care hospitals such as in lyon. the therapeutic means includes long-term circulatory assistance (vad). this type of circulatory assistance is becoming increasingly used in view of the shortage of heart transplants. indeed, the average waiting time on the paediatric transplant list varies from 3 months to over a year for children under 5. berlin heart excor (bhe) is the only long-term support available for children (2). it is a pulsatile para-corporeal assisting device with percutaneous cannulas. despite technical and medical advances in circulatory support, the presence of foreign material is frequently complicated by infection. infection is a major cause of morbidity and mortality in this population. it is most often of nosocomial origin, linked to central line infections. the germs associated with these infections are mainly bacteria, with a small proportion of fungi. the most common pathogens are multi-resistant gram-positive bacteria, which colonize the skin, adhere to the implanted equipment and create biofilms. infections have a major impact on the morbidity and mortality of patients undergoing mechanical assistance, with an increased risk of thrombo-embolic events and difficulty in managing anticoagulation, secondary to inflammation.

there are few literatures on the management of infections under mechanical assistance. current ishlt (international society for heart and lung transplantation) recommendations are based on expert opinion and observational studies. actual recommendations are long-term anti-infective therapy, even up to the time of transplantation in the case of assistance-specific or assistance-associated infections. at the hospices civils de lyon, bh-assisted patients awaiting transplantation are cared for in the paediatric cardiac intensive care unit (pcicu). infections are managed jointly with the infectious diseases team, through weekly consultations and rcp. the management strategy is directed towards the rational use of antibiotics and antifungals, to limit the impact of broad-spectrum, long-term antibiotic therapy on the microbiological environment and on the patient. the duration of anti-infective therapy is limited on the basis of clinical and biological criteria. in some cases, recurrence of the infectious episode may occur. this study will provide information on the therapeutic strategy for vad infections.

Eligibility criteria:
* inclusion criteria \* : * age \< 18years old * berlin heart excor implantation * exclusion criteria \* : * none

Keywords: berlin heart excor pediatric vad infections heart failure implanted material infection.
adjuvant whole breast irradiation in five fractions versus fifteen fractions in early breast cancer

Conditions: Study on Breast Cancer Patients

Summary: the study aiming for compairing results of hypofractionaton radiotherapy treatment in patient with early breast cancer between two arms the first arm recieving five fractions and the other arm recieving fifteen fraction


Eligibility criteria:
inclusion criteria: * age group ( 18-80) years * breast conservation surgery * stages (pt1-3, pn0-1, m0) breast cancer. * any histological type of invasive breast cancer. * all grades of breast cancer (i,ii,iii) exclusion criteria: * stage (iii or iv) breast cancer. * metastatic breast cancer (mbc) * recurrent breast cancer. * patients' co-morbidities that contraindicate radiotherapy
collaboration between department of old age psychiatry and nursing homes

Conditions: Dementia; Alzheimer's Disease; Behavioral Symptoms; Agitation

Summary: dementia is a serious health problem showing an increasing prevalence rate with increasing age. in norway, about 80% of nursing home patients have dementia. the mean age of nursing home residents in norway is around 84 years. disruptive and agitated behaviour affect 30-50% of all individuals with dementia at some point in the course of the illness. in addition, they have a combination of physical and psychological diseases which necessitates a close collaboration between different specialities in medicine and old age psychiatry. in collaboration with the communalities, our old age psychiatry services want to provide a new approach to this challenge and validate it on patient and personnel level.


Eligibility criteria:
inclusion criteria: * all patients at nursing home units exclusion criteria: * patients that are in a final state and patients that have not been at the nursing home unit more than two weeks

Keywords: dementia bpsd quality of life person-centred care job satisfaction nursing home primary care
universal screening for tuberculosis and anemia with the chica system

Conditions: Tuberculosis; Iron Deficiency Anemia

Summary: the chica system is a clinical decision support system that uses adaptive turnaround documents to provide point-of-care information to clinicians. the investigators will be studying whether it can help in the diagnosis and treatment of tuberculosis and iron deficiency anemia.

the chica system is a clinical decision support system that uses adaptive turnaround documents to provide point-of-care information to clinicians. we will be studying whether it can help in the diagnosis and treatment of tuberculosis and iron deficiency anemia.

Eligibility criteria:
inclusion criteria: age 3 to 11 years old and seen in a study clinic exclusion criteria: none

Keywords: chica clinical decision support
a study of dexmedetomidine pharmacokinetics for preoperative sedation

Conditions: Anxiety; Preoperative Care; Pharmacokinetics; Emergence Delirium

Summary: proper preoperative sedation can reduce patients' anxiety, enhance patients' cooperation and reduce perioperative complications. the investigators would explore the sedative effects of dexmedetomidine (dex) with the administration of oral, intravenous and nasal drops, and detect dex blood concentration in 15 participants, respectively. pharmacokinetic parameters are detected at 8 time points ( before dex administration, 10 min, 20 min, 30 min, 45 min, 60min, 90min and 120 min after administration). 3 ml arterial blood was collected at each time point. the blood samples are detected by mass spectrometer. the aim of this study is to investigate appropriate administration time and route for dex sedation.


Eligibility criteria:
inclusion criteria: * 45 participants who undergo tympanoplasty would be enrolled after signment the informed consent. exclusion criteria: * the participants were excluded with any diseases about respiration, circulation, liver and kidney.

Keywords: dexmedetomidine
study to evaluate the immunogenicity, safety, and tolerability of a tick-borne encephalitis (tbe) vaccine in healthy japanese participants 1 year of age and older

Conditions: Tick-Borne Encephalitis

Summary: the main purpose of this study is to provide safety and immunogenicity data in japanese participants.


Eligibility criteria:
inclusion criteria: * japanese male or female participants ≥1 years old at visit 1. * participants and/or a legally acceptable representative/parent/legal guardian are willing and able to comply with all scheduled visits, vaccination plan, and other study procedures including completion of the e-diary for 7 days for participants after each of 3 vaccinations. * participants and/or a legally acceptable representative/parent/legal guardian must be able to be contacted by telephone during study participation. * participants and/or a legally acceptable representative/parent/legal guardian are capable of giving signed informed consent. exclusion criteria: * major known congenital malformation or serious chronic disorder. * known history of tbev infection. * known history of other flavivirus infection (eg, dengue fever, yellow fever, jev, west nile virus). * known history of infection with hiv, hcv, or hbv. * immunocompromised participants with known or suspected immunodeficiency. * history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention. * previous vaccination with any licensed or investigational tbe vaccine, or planned receipt of other flavivirus vaccines apart from jev vaccine (eg, yellow fever, dengue fever) during the study. administration of jev vaccine is prohibited during participation.
effects of total knee replacement on early postoperative cognitive function in elderly patients

Conditions: Perioperative Complications

Summary: to investigate the effects of total knee replacement is harmful to postoperative cognitive dysfunction

postoperative cognitive dysfunction (pocd) is reported to occur after major surgery in elderly patients. they may especially experience problems in the weeks and months after surgery. recent studies vary greatly in methods of evaluation and diagnosis of pocd, and the pathogenic mechanisms are still unclear. the investigators evaluated a large uniform cohort of elderly patients in a standardized approach after total knee replacement.

Eligibility criteria:
inclusion criteria: * aged ≥65 years; * asa i or ⅱ; * total knee replacement exclusion criteria: * mini mental state examination \[mmse\] score too low. * parkinson or other neurological disease causing functional impairment. * patients with a history of alcohol abuse (≥35 u per week) or daily use of anxiolytics were also excluded, as well as those with severe hearing or visual impairment.

Keywords: postoperative cognitive dysfunction
preoperative combined radiochemotherapy for patients with rectal carcinoma

Conditions: Rectal Cancer

Summary: rate of t-downstaging (reduction of the t-stadium) at the time of final surgery following the preoperative combined radiochemotherapy (chemotherapy: oxaliplatin, capecitabine) evaluation of the toxicity grade iii and iv of the therapy scheme

about 60 patients with locally advanced rectal carcinoma (ct3, nx, m0) of the lower and middle rectum will be recruited. the radiotherapy is an essential part of therapy of the advanced rectal carcinoma and the additional administration of a chemotherapy will positively influence the effect of the therapy (downstaging-rate, rate of distant metastases, survival-rate). probably a downsizing and downstaging (as per literature and by own experience) can be reached with an preoperative combined radiochemotherapy.

Eligibility criteria:
inclusion criteria: * age: 18 - 80 * biooptical confirmed adenocarcinoma of the lower und middle rectum (lower edge of the tumor located max. 14 cm of the anal verge) * according to mri tumor extensions into the perirectal fat tissue (ct3) * no former chemotherapy, radiotherapy and/or tumor resection of a rectum carcinoma * who performance status 0 - 2 * adequate bone marrow reserve (leucocytes - not more than 3.000/ml; thrombocytes - not more than 100.000/ml) * adequate hepatic function (bilirubin - not more than 1.5 x uln; got and gpt - not more than 3.5 x uln) * adequate renal function (creatinin - not more than 1.5 mg/dl) * women of childbearing potential: exclusion of pregnancy (negative urin or serum pregnancy test) * willingness of women of childbearing potential and accordingly of potent men to use approved contraceptives (for example birth-control pill, loop, condom) during and at least 3 month after closure of the study * life expectancy of at least 3 month * signed written informed consent before recruitment * exclusion of distant metastases at the time of recruitment exclusion criteria: * former radio- and/or chemotherapy * tumor of the upper rectum * any other kind of malign tumor in the last five years (except adequate treated basal cell carcinoma of the skin, or in situ cervical carcinoma) * peripheral neuropathy (nci ctc - not higher than grade 1) * general contraindication or hypersensitivity against oxaliplatin and/or capecitabine * any other untreated not malign diseases: cardiac insufficiency, angina pectoris, hypertension or arrhythmia, hepatic diseases, significant neurological or psychiatric disorders * florid, serious infection at the time of recruitment * legally limited capacity or evidence of a neurological or psychiatric disease, the investigator is the opinion it will constrict the patients compliance * evidence of lacking willingness for cooperation of the patient * pregnant or breast feeding women

Keywords: preoperative radiochemotherapy newly diagnosed primary operable locally advanced rectal carcinoma t3 lower rectum middle rectum abcsg tako 95 05
extension study to evaluate the long-term safety and tolerability of mbx 2109 in patients with hypoparathyroidism

Conditions: Hypoparathyroidism

Summary: the purpose of this study is to evaluate the long-term safety and tolerability of mbx 2109 in patients with hypoparathyroidism who completed the 12-week treatment period in the phase 2 study, mbx-2h1002.

this study is to investigate the long-term safety and tolerability of mbx 2109 administered once weekly to patients with hypoparathyroidism. additionally, the ability of mbx 2109 to maintain serum calcium levels within the normal range without the need for active vitamin d and to reduce elemental calcium supplements to ≤600 mg/day.

Eligibility criteria:
key inclusion criteria: 1. must have completed the week 12 visit in mbx-2h1002 study. 2. is an adult ≥18 years of age at the time of the screening visit of this extension study. 3. has a diagnosis of one of the following types of hypoparathyroidism for at least 26 weeks prior to the screening visit: 1. postsurgical chronic hypoparathyroidism 2. idiopathic hypoparathyroidism 3. autoimmune hypoparathyroidism 4. can comprehend and is willing to sign an informed consent form (icf), and abide by the study restrictions, study visits, and procedures. 5. in the opinion of the investigator, must be able to successfully demonstrate reconstitution and self-administration of study drug.

Keywords: hypoparathyroid hypopara thyroid mbx 2109